Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 140 - 160)



John Austin

  140. Can I press you on two points, one in relation to the adverse incidents and the other on the Registry. You were talking earlier about the need for more information, more research, and Dr Stoate was referring to the current system really being unrestricted clinical trials. I gather, Dr Ludgate, you are responsible for management and use of data in the Registry. One of the criticisms we have received is that the data supplied is supplied on a voluntary basis.
  (Dr Ludgate) Yes.

  141. The first question is is that a valid criticism? Secondly, could you give us any indication of the progress and use of the Registry and what uptake there has been by surgeons in relation to any research findings that have come out from that Registry?
  (Dr Ludgate) Yes, it is voluntary. One of the recommendations of the Independent Review Group in their review, which you have seen, was that it should be compulsory. Legal advice is that we cannot do this because it takes away freedom from the woman and it almost amounts to coercion, so it has to remain voluntary.

  142. I think the lawyer who we were listening to earlier was saying that it would be anonymous data. Is your legal advice still that it would contravene some human rights?
  (Dr Ludgate) Yes, it is. That was our legal advice, that you cannot force women to go on to the Registry if they do not want to do so, and some do not want to do so.
  (Ms Stuart) In terms of data there will come a stage when we can properly encrypt data. For proper research to be done, on the one hand you can get anonymised data but if you have an adverse incident there must be a way in which you can trace it back. At the moment there will be a consent form to make absolutely sure there is always a right there. It is not right to say that it will be totally anonymised. I think the whole debate at the moment on consent is it has to be right, it has to be informed consent. I do not think we could get to a position where we could say a register is compulsory. The Chairman made the point earlier himself that they may not want their own GP to know this. If a woman was to say "I do not want to go on the register", we would then be in a position to say "in that case you cannot have the operation".

  143. Let us move from the register to the adverse incidents because it is obligatory, is it not, to notify adverse outcomes to you?
  (Dr Ludgate) There are a number of strands to this. The regulations say that manufacturers must report serious adverse incidents to the regulatory authority and what constitutes a serious adverse incident is laid down in the regulation and in the guidance documents that underpin it. In fact, we get as many reports directly from clinicians and patients as we do via that system. It is a bringing together, if you like, of information from all sources.

  144. How do you react to Dr Myhill's evidence given to us where she says in relation to a sub-group of over 100 patients with chronic fatigue syndrome following silicone breast implants: "During the early years I reported these cases individually to the medical Devices Agency, but when it became clear to me that they took no action whatsoever to investigate these cases further, I gave up reporting. More recently I have simply told them the numbers of patients affected and the symptoms from which they suffer. The Medical Devices Agency has not asked for any further information nor investigated any of these either as a group or singly"?
  (Dr Ludgate) We do add all these to a body of evidence. At one time we were not investigating each one individually. As an Agency we were looking at the adverse incidents of the devices, so we were not looking at each individual person and their ill-health, we could not do that. What we were doing was compiling a document that set this all out and, indeed, when the Independent Review Group met this was evidence that we submitted to them as part of the evidence. We felt it was very important that evidence directly from women and their adverse events was, if you like, put to them for their evaluation in terms of the conclusions that were drawn, and we do this in an ongoing way. We now actually register each woman individually if they are registered with us and then we feed that information through to the Independent Review Group as part of the evidence that they consider at each of their meetings.[66]

  145. Can I just follow this through. The evidence we had this morning was that very rarely is this a single operation and the likelihood of requiring further surgery and further intervention is highly likely. I raised the issue earlier of a young woman undergoing this kind of implant surgery and clearly the younger they are the more likely a number of later interventions. I quoted the example of a teenager getting a boob job for her birthday present from her parents, which I think all of us would find quite disturbing. Is the Department doing anything in terms of guidelines and guidance to practitioners regarding the use of implant techniques on young women who may not have fully developed?
  (Ms Stuart) I think in the particular case you refer to, which was in the press, when medical advice was given they withdrew that. You will find that the vast majority of the Department's professional recommendations to surgeons make quite clear the clinician's responsibility also in that to give the appropriate advice. Some people have suggested that we should say we should outlaw it for under 16 year olds but with that harshness of the law there may be a 15 year old with some congenital problems where it may be appropriate. We do feel that in the professional guidelines, particularly with the Royal College of Surgeons, we keep strengthening them and we keep reminding them. Can I come back to something that was said earlier when you were talking about the reporting of adverse incidents and the impression that was given that the women themselves could not do that.


  146. That was their impression.
  (Ms Stuart) When I looked at this—and I think the Select Committee here can take credit for that—my first reaction was to say "the MDA is not on there". I can assure you on the reprint it will be on there. I also looked at the letters which the MDA send out to women in response to reporting an adverse incident and it is quite clear that they have tried to differentiate between a report of ill-health, which the Agency could not take up and they urged them to have looked at further, and what is an adverse incident. Looking at the figures of the MDA, they have investigated 360 adverse incidents closely. What was interesting to me was that 66 of those were referred by women, 68 of those were referred by GPs, and there was one GP who took a very great interest, 68 from the hospital and then the rest, something like 158, from manufacturers and other sources. I was pleasantly surprised when I looked at the split that the largest numbers came from the manufacturers, which I thought was right and proper, but a very significant number came from the other routes. I do take on board that we probably have to make it much clearer that there is a direct line but at the same time I think we also need to be clear as to what is an adverse incident of the device and maybe something like ill-health. It would be equally damaging if anybody got the impression that it may have been an ill-health thing and by reporting it to the MDA that would resolve it. It is a two-way valve.

Dr Stoate

  147. I am still quite confused about the messages we are getting in this inquiry this morning. We have heard from the IRG that there is no statistical evidence that these implants cause any great damage, particularly the silicone ones, and yet we have heard from the support groups and patients that there are hundreds of cases, if not thousands, that they have got on their books of people who have complained of various reactions which they at least attribute to their problems. There is clearly a huge disparity here. I was concerned to hear in this post marketing surveillance idea that the manufacturers themselves decide what constitutes post marketing surveillance. If it is as loose as that, how do manufacturers know what adverse reactions there are? Who tells them? How do they get to find out? If they are only carrying out a sort of vague postal survey every now and again, how do they know what the true story is?
  (Dr Ludgate) There are two things here. The first is, yes, you are absolutely right, how do they know? The MDA have prepared a booklet that sets out very clearly what should be reported to us. This was written for manufacturers but we also promote it to surgeons.

  148. How do they know themselves? If they are only carrying out fairly loose and weak surveys, how do they know that is going on out there? They could be blissfully unaware of the reactions.
  (Dr Ludgate) Absolutely. The second strand that we are pushing at the moment, along with our improvements in Europe, is to promote a much better post market surveillance programme. At the moment, as I have said, all it says is there must be a post market surveillance programme. We are pushing to produce guidance that lays out very specifically exactly what manufacturers have to do in terms of getting information from surgeons, from hospitals, etc. and, again, that is something that has been taken up very favourably by other Member States.

  149. I will continue to draw my parallel with drugs because, as I say, I am a doctor and I see both sides of the argument. If a new drug comes on to the market a little triangle is put against that drug saying "special reporting required by the CSM of any adverse reactions", a yellow card scheme to openly criticise, and the yellow card scheme works at least to a large extent. There is a special triangle, it comes up on my computer on my desk, it is in Mimms, it is everywhere, "special reporting required" and GPs are alerted to the fact that they must report adverse incidents. Why can we not have a yellow card scheme for devices where there is special reporting required, where GPs and other health professionals are required to notify possible adverse reactions, so at least they could be statistically collated and patterns looked for and if there were a pattern developing it would be picked up sooner rather than later in the same way that many drugs have come on to the market in a huge blaze of publicity, stuck around for a couple of years and then gone off again very quickly when the yellow cards start dropping onto the mat? Why do we not have the same level of proof for the safety of these devices?
  (Dr Troop) The Medical Devices Regulations are much more recent than the drugs. There are the European regulations within which the MDA are working. There is clear recognition from us that the regulations around devices are not tight enough, as you describe. So the MDA has been pushing more than any other Member State for, first of all, these devices to be in the higher risk category in which case they would have to have more clinical data in the way that you have described before marketing and they would gain support. That has been led by the MDA. Equally, the whole issue of standards around Europe has been questionable and we have been concerned about that, so again the MDA have led to try to change the regulations across Europe. They are relatively new regulations, not like the MCA. What has happened is the recognition has come from us in the UK that they are not tight enough and the MDA has been leading in Europe to try to change those regulations. You are quite right, the situation is not there yet and, therefore, there are a number of areas that we would consider unsatisfactory but there are European regulations to which we are working.

  150. I am very pleased indeed that the British Government is taking the lead on this, that is obviously extremely reassuring and all one can say is all power to your elbow in making sure we do get the regulations tightened up across Europe because clearly there are significant gaps at the moment.
  (Dr Ludgate) We do have a system very similar to the yellow card system for devices. Indeed, we have over 7,500 adverse incidents of devices now reported annually to the Medical Devices Agency for investigation.

Siobhain McDonagh

  151. This is a bit of a long question so I am going to have to read it out to make sure I get it right, so forgive me if I am a bit monotone. Women opting for Trilucent implants might have assumed that they were safe on having them fitted. They were then told in March 1999 that there were doubts about the safety of these implants. The Advice Notice stated that "there was no safety information to suggest that removal of Trilucent breast implants was indicated but that women should be advised to seek an immediate clinical consultation if they noticed unusual breast swelling or inflammation associated with their Trilucent breast implants". Finally, over a year later in June 2000 they were told to have them removed because of potential genotoxic components and you, Dr Troop, said that the risk of cancer or damage to an unborn baby "could not be ruled out". This seems an extraordinary sequence of events. How can you justify giving such contradictory advice and why were women not advised to have the implants removed when you first became aware of the risk?
  (Dr Troop) I can pick that up but also Dr Ludgate was very much directly involved with the work. It was a progression of understanding about these. Each response was thought to be proportionate to the evidence that was there at the time. So when some evidence and information came that there were concerns there was the advice that they should not be used. Further work was done to investigate that a lot further to find out the extent of that and then this further evidence came to light and, therefore, they were recommended to be removed. It does go back to the whole question that we have raised before, that at the moment these are not in the high risk category and, therefore, this clinical data was not required before manufacture to the same level. It was in post market surveillance that this information was found out. The MDA acted promptly on each occasion, I think. On the first set of evidence they gave what was a proportionate response to the evidence that they had. At that stage the evidence did not justify recommending removal at the time but they continued to investigate and after they found further evidence they recommended removal. Dr Ludgate was directly involved in that.
  (Dr Ludgate) I think this illustrates quite nicely factors about the adverse incidents system and how things can work quite positively. We first became aware of a possible problem when a number of women reported to us that they were getting swelling of the breast in association with rupture, which was something quite new.

  152. Was it the women themselves who brought it to your attention?
  (Dr Ludgate) Absolutely. We got it from the women themselves.[67] This was something that had not been reported before, it was something quite new. We then went and we discussed this because we did not know—there were only a few—whether this was one or two anecdotes or whether it was more general. We went to the professional bodies who very helpfully contacted their surgeons and said "if you have any problems of this kind could you bring it immediately to the attention of the MDA". It was because of the numbers that we had in that respect that we immediately said that we would have to look at the safety here, there was something going on we did not understand. We called for the dossier from the manufacturers, we looked at all their safety data, and we were not happy that they had carried out the full tests that we considered necessary at that time, so immediately we said there should be no more implanted. But there was nothing in that evidence from the manufacturer that gave rise to any concerns at all at that time in terms of safety. We immediately insisted that further toxicological tests were carried out and the minute those came to light and we realised that there was a small chance that the break down products of the filler could result in genotoxic effects we recommended that they were explanted. Why did we not recommend explant beforehand? Firstly, because there were no safety issues at that time but, more importantly, removal of an implant is not without risk so you do not want to go in and be giving people anaesthetics without risk. Also Trilucent implants are actually quite difficult to remove, they get very stuck down to the surrounding tissue, and it is a much bigger operation than just making a cut and whipping them out. It is actually quite a long operation and there is often a lot of bleeding and these patients need to stay in hospital for several days with drains in, etc. That was the series of events. We acted on adverse events immediately, we insisted on more toxicological tests immediately and we acted promptly as each of these came to light.

  153. I am trying to flick through my notes to find out the name of the other breast implant.
  (Dr Ludgate) The Hydrogel.

  154. Yes. We were told by a gentleman who gave evidence previously, who was a solicitor, of women on his books who had had one implant and then the information was that was not safe, had it changed to another implant only to find out there was a suggestion there might be a factor of that being unsafe and had to have a third. So these women have gone through probably quite terrible—
  (Dr Troop) When the women were advised to have the first ones taken out there was information given on all of the alternatives and on the Hydrogel it was stated at that stage that the MDA did not have information about long-term safety. They did not have information that suggested there was harm but neither did they have information about long-term safety and they made that quite clear in the information that went out at the time. That is one of the problems of not having information but not necessarily having information about harm. They did give that information out at the time saying they could not say what the long-term safety is of this implant. That was as honest an appraisal of the implant that they could make at the time. They did not say that these were a safe alternative.

Dr Stoate

  155. You mentioned that it is a difficult operation to remove a Trilucent implant, and I have heard exactly the same thing, so it begs the question how do they get a CE stamp for something that actually is quite a dodgy thing to remove? We have know from the evidence that we have heard that women have to have these implants removed for all sorts of reasons and yet it is a technically very difficult procedure.
  (Dr Ludgate) It comes back to the importance of having pre-market clinical trials, which is what we are fighting for.

  156. I hope that will be common in the future.
  (Dr Ludgate) That is not something you can tell in any other pre clinical studies.

  157. Just on another point about this safety issue. According to the evidence we have received, the MDA have actually said that we should not use Trilucent breast implants because there is no evidence as to their safety and yet the same evidence we have received says we should not stop using silicone implants because there is no evidence that they are unsafe. That sounds contradictory and I think that is one of the reasons why people are so confused and why we have had confusing evidence this morning. It seems to me that there is a dual message: you cannot use Trilucent because there is no evidence of safety and you must not stop using silicone because there is no evidence of their lack of safety.
  (Dr Ludgate) The toxicological tests that were done on the Trilucents and the Hydrogels were quite clear. In the Trilucent case the toxicology has been looked at and there are question marks over it. With the Hydrogels we have said do not use any more because there are no safety issues over it but we do not have the data. With silicone the toxicological safety data has been assessed and there is no evidence based on that toxicological assessment of it being unsafe. So we have, in fact, been quite consistent across the three implants. The toxicology of each of these has been looked at in turn. In one case it has come out as safe, in one it is unsafe and let us take them out and in the third we are doing it and we are awaiting further toxicological results.

John Austin

  158. There is a moratorium, or a ban, on the use of silicone breast implants in the United States, Canada and Australia. Do you think that women in this country ought to be aware that those countries all ban the use of silicone breast implants?
  (Ms Stuart) At the same time in the whole of Europe it is available. France banned it for a period but has now reintroduced it. What has been happening over the last few years is that we have tried in as public a way as possible to make information available in a variety of ways. What is quite interesting, and it takes us to what we are discussing here in terms of risk assessment and almost takes us beyond the specific issue in the Committee, is that in a sense we have got choices as a Government, as a society, as individuals. We either say totally precautionary and until something is proved to be absolutely safe we will not do anything or, on the other hand, we say let us try it until it is unsafe. What we have tried to do is have a continued progression and as long as the benefits outweigh the risks we will continue the review. We have got the adverse reporting, the reviews of the evidence, and we make it absolutely public, and that includes the doubts.

  159. If you were contemplating it and you knew that it was banned in Australia, Canada and the United States, would the fact that you knew it was banned in those countries not make you think twice or find out the risks and why it had been banned in those countries?
  (Dr Ludgate) It is actually not banned in the United States. They are allowed within clinical trial situations and for reconstruction. Although there was a moratorium for a short period of time, it has not been banned completely. I just make that clear.


  160. I think the concern is perhaps if a person within this country approached a surgeon in the private sector for this operation and the same process happened in the States, in the States that would not be able to go ahead. Is that correct?
  (Dr Ludgate) That is correct.[68]

  Chairman: That qualifies the answer I think. Any further questions? If not, can I thank you, Minister, and your colleagues for a very helpful session, we are most grateful to you.

66   Note by witness: Since 1997, each case reported by Dr Myhill was logged by MDA and a copy of a specific reporting form was sent to her for completion by the patient. Most of these have been returned and thus included in the evidence considered by the IRG. Back

67   Note by witness: Cases of swelling were predominantly reported to MDA by the manufacturer, in line with statutory reporting requirements. Back

68   Note by witness: In the USA, silicone gel-filled implants are available to women through two FDA-approved clinical studies, one for women seeking breast reconstruction or the revision of an existing breast implant, and a second study designed to meet US regulatory requirements for pre-market clinical data. Back

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